Clinical Value of 89Zr-trastuzumab PET

Metastatic Breast Cancer Clinical Trial

Official title:

HER2-PET as a Diagnostic Tool in Breast Cancer Patients With a Clinical Dilemma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832051
• Other study ID #: Her2.4
• Status: Completed
• Phase: Phase 2
• First received: April 3, 2013
• Last updated: November 4, 2015
• Start date: March 2013
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor lesions in breast cancer patients is essential for diagnostic and therapeutic management of metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional information, have so far not been able to replace the biopsy. To solve this problem, non-invasive whole body visualization and quantification of HER2 expression by means of the HER2-PET may be a valuable tool.

In this prospective multicenter imaging study, eligible patients will receive one HER2-PET and CTC analysis in addition to standard work up for metastatic disease. Subsequent administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three questionnaires, one before HER2-PET and two after HER2-PET.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. In the Netherlands HER2-positivity is defined as:

• HER2 immunohistochemical score of 3+, or

• HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification.

In Belgium HER2-positivity is defined as positive FISH for HER2/c-erbB2 amplification.

2. Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma:

• in whom standard work up with imaging has failed to solve the clinical dilemma (diagnostic/therapeutic), leaving issues with regard to HER2 status of lesions and

• in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise.

3. Standard work-up with imaging is defined as CT chest and abdomen, bone scintigraphy, as well as FDG-PET.

4. Age >18 years of age.

5. WHO performance status 0-2.

6. Signed written informed consent.

7. Able to comply with the protocol.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.

3. Inability to comply with study procedures

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• 89Zr-trastuzumab injection

Locations

Country	Name	City	State
Netherlands	University Medical Center	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance between HER2-PET results and anti-HER2 therapy	Concordance between HER2-PET results and anti-HER2 therapy is defined as HER2 positive lesion(s) on HER2-PET and subsequent anti-HER2 therapy; or no HER2 positive lesions on HER2-PET and no subsequent anti-HER2 therapy. It is considered a clinically relevant contribution of HER2-PET to anti-HER2-therapy decisions if there is a concordance in at least 2/3 of included patients.	about 2 years (end of study)	No
Secondary	Correlation of HER2-PET results and questionnaire results regarding clinical value of HER2-PET for the referring clinician	Correlation of HER2-PET result (assessed about 1 week after scan) and questionnaire results (before, directly after, and 3 months after scan)	about 2 years (end of study)	No
Secondary	Correlation of HER2-PET results with standard conventional work-up	Correlation of HER2-PET result (assessed about 1 week after scan) and standard conventional work-up (assessed before/at screening)	about 2 years (end of study)	No
Secondary	Correlation of HER2-PET results and HER-2 expression by CTCs	Correlation of HER2-PET result (assessed about 1 week after scan) and HER-2 expression by CTCs (blood for CTC analysis will be drawn at day of tracer injection, analysis within 3 days)	about 2 years (end of study)	No